Unique ID issued by UMIN | UMIN000051675 |
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Receipt number | R000058969 |
Scientific Title | Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/07/21 |
Last modified on | 2024/04/19 09:16:31 |
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the bowel movement in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on the bowel movement in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of defecation frequency in period V*
*Period V: 22~28 days after consumption
1. The defecation frequency in period II, III, and IV*
2. The numbers of defecation days and amount of defecation in period II, III, IV, and V*
3. Each state of stool shape, stool smell, and exhilarating feeling of defecation in period II, III, IV, and V*
4. The score of the Constipation Assessment Scale Middle Term version (CAS-MT), subjective fatigue, and "sleepiness on rising", "initiation and maintenance of sleep", "frequent dreaming", "refreshing" and "sleep length" in the OSA sleep inventory MA version (OSA-MA) at two and four weeks after consumption (2w, 4w).
5. The occupancy rate of bacteria in the stool, the diversity index, mucin in the stool, immunoglobulin A (IgA) in the stool, the stool pH, organic acid levels (acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, and formic acid) in the stool, salivary cortisol, and the serotonin in the blood at 4w
6. Each item of CAS-MT and the OSA-MA at 2w and 4w
*Period I: The seven days prior the screening (before consumption; Scr)
Period II: The seven days after initial consumption
Period III: 8~14 days after consumption
Period IV: 15~21 days after consumption
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
3
Treatment
Food |
Duration: Four weeks
Test food: Supplement containing Lactococcus lactis subsp. cremoris Flora aid (50 mg)
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Four weeks
Test food: Supplement containing Lactococcus lactis subsp. cremoris Flora aid (100 mg)
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Four weeks
Test food: Placebo supplement
Administration: Take one capsule per day with water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose defecation frequency is three to five times per week
6. Subjects whose defecation frequency is few in seven days prior to Scr
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have lactose intolerance
5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
6. Subjects who use or take medicines, "Foods for Specified Health Uses," or "Foods with Functional Claims" with intestinal regulating effects in daily
7. Subjects who are currently taking medications (including herbal medicines) and supplements
8. Subjects who are allergic to medicines and/or the test food related products
9. Subjects who have a smoking habit
10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
12. Subjects who are judged as ineligible to participate in this study by the physician
30
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
NICORIO
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 07 | Month | 21 | Day |
Unpublished
36
Completed
2023 | Year | 06 | Month | 26 | Day |
2023 | Year | 06 | Month | 26 | Day |
2023 | Year | 07 | Month | 21 | Day |
2023 | Year | 10 | Month | 29 | Day |
2023 | Year | 07 | Month | 21 | Day |
2024 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058969
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